What is the KRPIA?

The Korean Research-based Pharmaceutical Industry Association (KRPIA) is a significant trade organization in South Korea that represents multinational pharmaceutical companies. KRPIA plays a critical role in shaping the South Korea’s pharmaceutical industry, focusing on research and development (R&D), by advocating for policies that support regulatory reform, innovation and ultimately patient access to novel and efficacious therapies. It also aims to foster collaboration between domestic and international stakeholders to improve healthcare standards and ensure that Korean patients have access to the latest medical advancements.

What role does the KRPIA play in the regulatory environment of South Korea?

Promotes Innovation in Healthcare: KRPIA promotes policies that support research and development (R&D) for innovative therapies. The association works with government authorities and industry partners to ensure a favorable environment for pharmaceutical companies that invest in developing new drugs and treatments.

Advocacy and Policy Influence: KRPIA advocates for a regulatory framework that allows for swift approval of new drugs, intellectual property rights protection, and fair pricing and reimbursement policies. They aim to balance accessibility for patients with incentives for innovation.

Transparency: KRPIA promotes transparency in business dealings, including interactions with healthcare professionals and institutions. This includes disclosing payments to healthcare providers, reporting clinical trial results, and ensuring that marketing practices are ethical and patient-focused.

Global Partnership: KRPIA represents global pharmaceutical companies in Korea, facilitating the introduction of new, internationally developed medicines to the South Korean market. It also helps Korean companies collaborate globally in areas such as clinical trials, technology transfer, and joint R&D.

Health and Economic Impact: By supporting the introduction of innovative drugs, KRPIA helps to improve healthcare outcomes for patients in South Korea. Additionally, it contributes to the country’s economy through investments in clinical trials, R&D, and partnerships with local businesses.

Ethical Standards and Guidelines:

KRPIA adopts the International Federation of Pharmaceutical Manufacturers (IFPMA) Code of Practice, which guides ethical practices for the promotion of medicines and relationships with healthcare professionals. This code ensures:

• Responsible communication of drug information.
• Compliance with marketing regulations and non-promotional interactions.
• Strict adherence to rules regarding interactions with medical professionals, clinical trial participants, and patients.

DDReg’s Capabilities

As part of it’s regulatory services portfolio for the South Korean market, DDReg leverages its expertise to help customers navigate the complexities of local regulations. The team has a robust understanding of the South Korea MFDS requirements and can provide the necessary strategic support that foreign pharmaceutical companies are looking for in order to bring their novel therapies while ensuring compliance across the entire product lifecycle.